Yinghong Zhou , Siyu Sun , Ying Zhang , Zhaoxin Liu , Chenghai Liu , Jihan Huang
{"title":"Evolution of Clinical Trials of Systemic Therapies for Hepatocellular Carcinoma Between 2005 and 2024: Based on ClinicalTrials.gov","authors":"Yinghong Zhou , Siyu Sun , Ying Zhang , Zhaoxin Liu , Chenghai Liu , Jihan Huang","doi":"10.1016/j.gastha.2025.100725","DOIUrl":"10.1016/j.gastha.2025.100725","url":null,"abstract":"<div><div>This study aimed to evaluate the fundamental characteristics of clinical trials and changes over time in clinical trials of systemic therapies for hepatocellular carcinoma (HCC). Interventional clinical trials of systemic therapies registered at <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> from January 2005 to December 2024 were downloaded. Data on recruitment status, clinical phase, therapy type, trial design, outcome indicators, and other relevant factors were evaluated. A total of 1233 trials were included, of which 363(29.4%) were registered from 2005 to 2014 and 870 (70.6%) were registered from 2015 to 2024, reflecting the growing body of research on HCC. Regarding the intervention model type, single-group designs were employed in 679 (55.1%) trials, and parallel designs were employed in 489 (39.7%). A total of 209 trials were Phase 1 (17.0%), 152 (12.3%) were phase 1|phase 2, 560 were phase 2 (45.4%), 41 (3.4%) were phase 2|phase 3, 162 (13.1%) were phase 3, and 32 (2.6%) were phase 4. Small-molecule targeted agents, immune monotherapies, and targeted agent and immunotherapy combinations were the primary interventions, being used in 364 (29.5%), 434 (35.2%), and 287 (23.3) studies, respectively. Immune checkpoint inhibitors, particularly programmed death receptor 1 or programmed death ligand 1 antibodies, were the most studied immunotherapies. The development of systemic therapies for HCC have made significant progress in the past 2 decades, especially in the areas of immunotherapy and targeted therapy. The results of this study provide an important reference for the development of new HCC therapies and optimization of clinical trial design and treatment strategies.</div></div>","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 10","pages":"Article 100725"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144922056","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Teresa Del Rio MD, Blaire Burman, Asma Siddique, Erin Forsythe
{"title":"Refractory Celiac Disease Causing Cavitating Mesenteric Lymph Node Syndrome and Celiac Disease Associated Central Nervous System Demyelinating Disorder","authors":"Teresa Del Rio MD, Blaire Burman, Asma Siddique, Erin Forsythe","doi":"10.1016/j.gastha.2025.100738","DOIUrl":"10.1016/j.gastha.2025.100738","url":null,"abstract":"<div><div>Refractory celiac disease is a rare complex autoimmune-mediated disorder, which has multiple complications, among the best known is enteropathy-associated T-cell lymphoma, other rare complications are central nervous system demyelinating disorder and cavitary mesenteric lymph node syndrome. In our case report, we present a 43-year-old female with a known history of refractory celiac disease who developed a progressive demyelinating disorder of unknown origin and elevated liver enzymes that warranted further investigation. This led to the diagnosis of the cavitary mesenteric lymph node syndrome and celiac disease associated with demyelinating disorder that are both very rare presentations of refractory celiac disease. Treatment options for this case presented a challenge, firstly due to the lack of literature but also to continued complications.</div></div>","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 10","pages":"Article 100738"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144932404","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"A Systematic Review of Risk Prediction Models for Esophageal Adenocarcinoma in the General Population","authors":"Liyan Zhao , Binbin Chen , Jesper Lagergren , Shao-Hua Xie","doi":"10.1016/j.gastha.2025.100737","DOIUrl":"10.1016/j.gastha.2025.100737","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Risk prediction models can identify individuals at high risk of esophageal adenocarcinoma. This systematic review aimed to critically appraise the available models for projecting absolute risk of esophageal adenocarcinoma in the general population.</div></div><div><h3>Methods</h3><div>We searched Medline, Embase, and Cochrane Library databases for studies of risk prediction models for esophageal adenocarcinoma. Data were extracted from eligible studies according to the checklist for critical appraisal and data extraction for systematic reviews of prediction modelling studies. Risk of bias and applicability were assessed using the prediction model risk of bias assessment tool.</div></div><div><h3>Results</h3><div>We identified 7 studies. Age, sex, gastroesophageal reflux disease, body mass index, and tobacco smoking were the most common predictors. The area under the receiver operating characteristic curve ranged between 0.76 and 0.88 in the derivation datasets. The models based on 2 cohort studies showed good agreement between observed and predicted risks. All studies had at least 1 domain with high risk of bias, primarily attributable to methodological shortcomings in the data analysis.</div></div><div><h3>Conclusion</h3><div>Most risk prediction models showed good performance in identifying individuals at high risk of esophageal adenocarcinoma. Validation in external populations and cost-effectiveness evaluation are needed before these models can be applied in public health and clinical practice.</div></div>","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 10","pages":"Article 100737"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144907241","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Jessica Bradley , Caroline Olson , Ali Alghubari , Ramsah Cheah , Sadia Z. Shah , Augustine S. Lee , Kenneth R. DeVault , Lesley A. Houghton
{"title":"Delayed Gastric Emptying Neither Contributes to Gastroesophageal Reflux nor Disease Severity in Patients With Respiratory Disease","authors":"Jessica Bradley , Caroline Olson , Ali Alghubari , Ramsah Cheah , Sadia Z. Shah , Augustine S. Lee , Kenneth R. DeVault , Lesley A. Houghton","doi":"10.1016/j.gastha.2025.100733","DOIUrl":"10.1016/j.gastha.2025.100733","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Gastroesophageal reflux (GER) is common and thought to contribute to disease progression in patients with respiratory disease. Delayed gastric emptying (DGE) can increase GER in patients with GER disease, but its effect in patients with respiratory disease, and how differing lung structure (eg, scarring, inflammation) and mechanics (eg, decreased thoracic pressure in restrictive disease, increased abdominal pressure in obstructive disease) influences this is unknown. Our aim was to understand these interrelationships and association with pulmonary function in patients with chronic obstructive pulmonary disease (COPD), idiopathic pulmonary fibrosis (IPF) and non-IPF interstitial lung disease (non-IPF ILD).</div></div><div><h3>Methods</h3><div>We prospectively recruited 22 COPD (aged 34–75 years), 33 IPF (45–74 years), and 19 non-IPF ILD (37–74 years) patients who underwent gastric emptying studies, high resolution impedance manometry, 24-hr pH-impedance, and pulmonary function testing, as part of routine lung transplantation assessment.</div></div><div><h3>Results</h3><div>Gastric emptying was delayed in a total of 20(27%) patients; 5(23%) with COPD, 8(24%) with IPF and 7(37%) with non-IPF ILD. Notably, all 7 non-IPF ILD patients with DGE had nonspecific interstitial pneumonia (NSIP; ie, 70% of NSIP patients; <em>P</em> < .02 compared with other groups). DGE irrespective of disease type was not associated with increased acid exposure time, total bolus exposure time or number of reflux events. Furthermore, DGE was not associated with higher intra-abdominal pressure, specific esophageal dysmotility, or worse pulmonary function in any of the respiratory diseases.</div></div><div><h3>Conclusion</h3><div>Significantly more NSIP patients have DGE compared with other respiratory diseases. Irrespective of this, DGE had little effect on GER or pulmonary function in any of the respiratory diseases.</div></div>","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 10","pages":"Article 100733"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144920033","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Cover: Human Oral Microbial Consortium Associated With Periodontitis Attenuates Weight Loss in Dextran Sulfate Sodium-Induced Colitis","authors":"","doi":"10.1016/S2772-5723(25)00167-0","DOIUrl":"10.1016/S2772-5723(25)00167-0","url":null,"abstract":"","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 8","pages":"Article 100780"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145094603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Supine-Position Endoscopic Retrograde Cholangiopancreatography for a Patient With Severe Motor and Intellectual Disabilities","authors":"Kimitoshi Kubo , Issei Ashida , Noriko Kimura","doi":"10.1016/j.gastha.2024.06.014","DOIUrl":"10.1016/j.gastha.2024.06.014","url":null,"abstract":"","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 1","pages":"Article 100507"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141710315","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Bharathi Selvan, Melissa M. Tran, Christine O’Connell, Julius M. Wilder
{"title":"What Are TikTok Users Saying About Colorectal Cancer? An Examination of Content, Quality, and Emerging Themes","authors":"Bharathi Selvan, Melissa M. Tran, Christine O’Connell, Julius M. Wilder","doi":"10.1016/j.gastha.2024.08.013","DOIUrl":"10.1016/j.gastha.2024.08.013","url":null,"abstract":"","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 1","pages":"Article 100534"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11714384/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959722","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Andy Yu , Gabriel M. Knight , Justin Boike , Bartley Thornburg , Riad Salem
{"title":"Portal Vein Recanalization Transjugular Intrahepatic Portosystemic Shunt for Noncirrhotic Chronic Portal Vein Thrombosis Leading to Successful Pregnancy: Case Report","authors":"Andy Yu , Gabriel M. Knight , Justin Boike , Bartley Thornburg , Riad Salem","doi":"10.1016/j.gastha.2024.09.001","DOIUrl":"10.1016/j.gastha.2024.09.001","url":null,"abstract":"<div><div>Portal vein recanalization transjugular intrahepatic portosystemic shunt (PVR-TIPS) is a safe and effective procedure for decompression of portal hypertension (PH). In this short case series, 2 women with chronic noncirrhotic portal vein thrombosis were treated with PVR-TIPS. Both patients hoped to conceive. Without treatment for their PH, their pregnancies posed a significant risk of life-threatening variceal bleeding. Both patients tolerated the procedure well and delivered without complications of PH. In future cases of noncirrhotic portal vein thrombosis in patients hoping to conceive, PVR-TIPS should be considered for definitive treatment of PH.</div></div>","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 1","pages":"Article 100546"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11713488/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142959706","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Chethan Ramprasad , Divya Saini , Henry Del Carmen , Lev Krasnovsky , Rajat Chandra , Ryan Mcgregor , Russell T. Shinohara , Eric Eaton , Meghna Gummadi , Shivan Mehta , James D. Lewis
{"title":"Text Message System for the Prediction of Colonoscopy Bowel Preparation Adequacy Before Colonoscopy: An Artificial Intelligence Image Classification Algorithm Based on Images of Stool Output","authors":"Chethan Ramprasad , Divya Saini , Henry Del Carmen , Lev Krasnovsky , Rajat Chandra , Ryan Mcgregor , Russell T. Shinohara , Eric Eaton , Meghna Gummadi , Shivan Mehta , James D. Lewis","doi":"10.1016/j.gastha.2024.09.011","DOIUrl":"10.1016/j.gastha.2024.09.011","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Inadequate bowel preparation which occurs in 25% of colonoscopies is a major barrier to the effectiveness of screening for colorectal cancer. We aim to develop an artificial intelligence (machine learning) algorithm to assess photos of stool output after bowel preparation to predict inadequate bowel preparation before colonoscopy.</div></div><div><h3>Methods</h3><div>Patients were asked to text a photo of their stool in the commode when they believed that they neared completion of their colonoscopy bowel preparation. Boston Bowel Preparation Scores of 7 and below were labeled as inadequate or fair. Boston Bowel Preparation Scores of 8 and 9 were considered good. A binary classification image-based machine learning algorithm was designed.</div></div><div><h3>Results</h3><div>In a test set of 61 images, the binary classification machine learning algorithm was able to distinguish inadequate/fair preparation from good preparation with a positive predictive value of 78.6% and a negative predictive value of 60.8%. In a test set of 56 images, the algorithm was able to distinguish normal colonoscopy duration (<25 minutes) from long colonoscopy duration (>25 minutes) with a positive predictive value of 78.6% and a negative predictive value of 65.5%.</div></div><div><h3>Conclusion</h3><div>Patients are willing to submit photos of their stool output during bowel preparation through text messages before colonoscopy. This machine learning algorithm demonstrates the ability to predict inadequate/fair preparation from good preparation based on image classification of stool output. It was less accurate to predict long duration of colonoscopy.</div></div>","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 2","pages":"Article 100556"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11760837/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143049030","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Divya B. Dasani , Maria Isabel Fiel , Camila C. Simoes , Adam S. Morgenthau , Thomas D. Schiano
{"title":"The Varying Histology of Hepatic Sarcoidosis and the Relation of Bile Duct Damage and Loss to the Presence of Portal Hypertension and Cirrhosis","authors":"Divya B. Dasani , Maria Isabel Fiel , Camila C. Simoes , Adam S. Morgenthau , Thomas D. Schiano","doi":"10.1016/j.gastha.2024.10.001","DOIUrl":"10.1016/j.gastha.2024.10.001","url":null,"abstract":"<div><h3>Background and Aims</h3><div>Sarcoidosis is a multisystem disorder characterized by nonnecrotizing granulomas. Studies suggest 20%–70% of patients with sarcoidosis have abnormal liver chemistries or abdominal imaging. Hepatic sarcoidosis may be complicated by portal hypertension (portal HTN) with or without cirrhosis. Few studies have reviewed the liver histopathology of sarcoidosis.</div></div><div><h3>Methods</h3><div>Searching the pathology database using the terms “sarcoidosis” and “liver,” patients were identified and cross-referenced to patients in the Sarcoidosis Clinic. Patients met the diagnostic criteria for sarcoidosis. Those with isolated granulomatous hepatitis were excluded. Demographics, abdominal imaging, biochemistries, and detailed histological features were cataloged.</div></div><div><h3>Results</h3><div>Patients were separated into 2 groups: those with portal HTN with or without cirrhosis (pHTN+) and those without portal HTN (pHTN-). Fifty-three patients had biopsies available for review (pHTN+, n = 33; pHTN-, n = 20). The groups did not differ in the location, type, or number of granulomas. The pHTN + group had more bile duct damage (<em>P</em> = .025) and loss (<em>P</em> = .019). Patients in the pHTN + group also had biliary cirrhosis, nodular regenerative hyperplasia, or outflow obstruction.</div></div><div><h3>Conclusion</h3><div>There are several causes for portal HTN in sarcoidosis. Thus, liver biopsy is essential in its evaluation. Bile duct damage and loss are associated with the presence of portal HTN and cirrhosis. Biliary abnormalities may occur independently of granulomatous inflammation, and can thus identify a subset of patients at risk for progressive liver disease.</div></div>","PeriodicalId":73130,"journal":{"name":"Gastro hep advances","volume":"4 2","pages":"Article 100561"},"PeriodicalIF":0.0,"publicationDate":"2025-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11757786/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143049036","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}